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目的:确定O/W型外用“止痒乳”的处方和制备工艺。方法:采用均匀设计,以乳剂的稳定性参数为主要考察指标,综合评分考察了乳化剂用量、中药提取液量、乳化时间、温度等因素对中药乳剂质量的影响,与不含中药的乳剂相比较,筛选出O/W型“止痒乳”的优化处方和制备工艺。结果:验证试验结果满意,3批乳剂的Ke值、粘度值无明显差异(P>005),综合评分为9601,外观检查质量良好。结论:均匀设计适用于药剂学中处方筛选及工艺优化。
OBJECTIVE: To determine the formulation and preparation of O / W topical “itch milk”. Methods: Using uniform design, taking the stability parameters of emulsion as the main index, the effects of emulsifier dosage, extract volume, emulsifying time and temperature on the emulsion quality of traditional Chinese medicine were investigated. Comparison, screening out O / W type “itching milk” optimization prescription and preparation process. Results: The results of the validation test were satisfactory. There was no significant difference in Ke value and viscosity between the three batches of emulsions (P> 005). The comprehensive score was 9601 and the quality of appearance examination was good. Conclusion: The uniform design is suitable for prescription screening and process optimization in pharmacy.